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Draft Commission Directive Laying Down Principles and Detailed Guidelines for Good Clinical Practice as Regards Investigational Medicinal Products for Human Use, as Well as the Requirements for Authorisation of Manufacturing or Importation Of Such Products

Bibliographic Citation

Abstract

This proposed directive redrafts the original European Union clinical trials directive (2001/20/EC) that was developed to govern approval and monitoring of commercially-sponsored clinical research in countries of the European Union. This directive recognizes that clinical drug trials may be sponsored by non-drug companies and offers some different guidelines to govern non-commerical, non-profit research.